A Phase 2 interventional study of lebrikizumab and lebrikizumab in Asthma, sponsored by Genentech, Inc.. Completed at 64 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 205 is above the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: lebrikizumab
Drug: lebrikizumab
Drug: lebrikizumab
Drug: placebo
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
Rate of asthma exacerbations during the 52-week placebo-controlled period
Time frame: weeks 0-52
Change in lung function: pre-bronchodilator FEV1
Time frame: from baseline to week 52
Time to first asthma exacerbation
Time frame: from baseline to week 52
Change in fractional exhaled nitric oxide (FeNO)
Time frame: from baseline to week 52
Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])
Time frame: from baseline to week 52
Change in asthma rescue medication use
Time frame: from baseline to week 52
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Time frame: from baseline to week 52
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.